October 16, 2019

US Food And Drug Administration Issues Warning Letter To Torrent Pharma, Blaming Its Management For Violations

[ By Bobby Anthony ]


The United States Food & Drug Administration (FDA) has blamed Torrent Pharmaceuticals Ltd’s executive management of repeated violations across multiple plants in its warning letter to the company's Indrad plant in Gujarat.

In its warning letter, the US regulator has pointed out plant officials at both its Indrad and Dahej plants do not follow written procedures for drug manufacturing and their inability to thoroughly review unexplained discrepancy and failure of a batch of medicines.

It may be recalled that the US FDA had inspected Torrent Pharma’s facility in Dahej in March, after which it had issued certain observations which were later categorized as OAI.

The US regulator’s warning letter cited repeated failures at multiple sites, which it stated demonstrated that the executive management’s oversight and control over the manufacture of drugs is inadequate.

The regulator has directed the company to immediately and comprehensively assess its global manufacturing operations to ensure that manufacturing systems, processes, and products meet US FDA standards.

Incidentally, Torrent Pharma had informed stock exchanges that the US FDA had issued a warning letter to its Indrad plant after an inspection of the facility in April.

After the regulator inspected the Indrad facility in April, the US FDA had stated that the company had failed to thoroughly review any unexplained discrepancy and failure of a batch, and also failed to review written procedures.

Related Post

latest News

  • MCA Defends Insolvency & Bankruptcy Code Amendments; Tells SC That Strict Resolution Deadlines Are Important

    The Ministry of Corporate Affairs (MCA) has defended all amendments made to the Insolvency and Bankruptcy Code (IBC) in a recent submission made to th...

    Read More
  • No Stay On CAA, NPR, Says Supreme Court

    The Supreme Court has refused to pass any order to restrain the operation of Citizenship (Amendment) Act (CAA) or the National Population Register (NP...

    Read More
  • 21 day lock-down exempted for CIRP: IBBI amends CIRP regulations

    The Insolvency and Bankruptcy Board of India (IBBI) has amended the Insolvency and Bankruptcy Board of India (Insolvency Resolution Process for Corpor...

    Read More